PHARMACEUTICAL SUPPORT FOR STUDY OF CORONARY REVASCULARIZATION AND THERAPEUTICS EVALUATIONS (SOCRATES) NHLBI invites participation of the pharmaceutical industry in a large scale clinical trial involving the management of patients with ischemic heart disease. It will involve varied drugs used in the management of patients with stable coronary heart disease and angina, including long-acting calcium channel blockers with varied chronotropic and isotopic effects, beta adrenergic antagonists, ACE inhibitors, nitrates and statins. This study builds upon the findings and experience of the pilot Asymptomatic Cardiac Ischemia Pilot (ACIP) study and other advances in the overall management of patients with ischemic heart disease. It will test the strategy of using a maximum anti-ischemic regimen (i.e., medications titrated up to a maximum dose or to side effects) versus the customary angina-controlling strategy and versus the revascularization strategy. All patients will have stable angina, be eligible for all three arms and will also receive current comprehensive medical management of ischemic heart disease, including aggressive lipid management, anti-thrombotic therapy and life style risk modification. Several protocol-driven medical regimens will be utilized, as there will be multiple patient subgroups (based upon such factors as possible previous myocardial infarction, ejection fraction, and heart rate.) The primary endpoint will be survival free of MI. Other outcomes of interest include cardiac symptoms requiring hospitalization, recurrent ischemia, quality of life and cost. A total of 6,000 patients will be enrolled over a 24 month period beginning in the Summer of 2000 and will continue in the trial until the Fall of 2006. The framework for the protocol is detailed in the Request for Proposal NIH-NHLBI-99-14 which are available at http://www.nhlbi.nih.gov/nhlbi/rafs/hc9914a.htm. The final protocol will be developed by the study leadership that is being appointed and the participants who are being selected competitively. As in other clinical trials, the trial will proceed into the patient recruitment phase only after approval of the final protocol by an independent protocol review committee and then by NHLBI. Collaboration with the pharmaceutical industry would seem mutually advantageous. We would be pleased to hear of your interest in the matter and to respond to any questions you may have. Interested parties should express their interest by April 15, 1999 to Peter L. Frommer, M.D., Deputy Director Emeritus, (301) 435-0305, e-mail -- pf20m@nih.gov or Lawrence M. Friedman, M.D., Director Division of Clinical Applications and Prevention, (301) 435-0422, e-mail to lf13w@nih.gov. Posted 03/02/99 (W-SN303915).

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